Green v. Dolsky

• Decision Date: 10 May 1994
• Citation: 433 Pa.Super. 556,641 A.2d 600
• Parties: , Prod.Liab.Rep. (CCH) P 14,077 Irene M. GREEN and Martin Green, Appellants, v. Richard L. DOLSKY, M.D. and Collagen Corporation.
• Court: Pennsylvania Superior Court

Page 600

641 A.2d 600

433 Pa.Super. 556, Prod.Liab.Rep. (CCH) P 14,077

Irene M. GREEN and Martin Green, Appellants, v. Richard L. DOLSKY, M.D. and Collagen Corporation.

Superior Court of Pennsylvania.

Argued Feb. 15, 1994.

Filed May 10, 1994.

Lindley M. Cowperthwait, Jr., Norristown, for appellants.

Reeder R. Fox, Philadelphia, for Collagen.

Before CIRILLO, BECK and JOHNSON, JJ.

JOHNSON, Judge:

In this case of first impression, we are asked to determine whether the Medical Device Amendments of 1976 (MDA), 21 U.S.C. §§ 360c et seq., 360k, to the Federal Food, Drug, and Cosmetic Act of 1938 (FDCA), 21 U.S.C. §§ 513 et seq., 521(a), preempt state tort law claims involving Class III medical devices. Irene M. Green and Martin Green, her husband, appeal from the grant of summary judgment by the Court of Common Pleas of Montgomery County, in favor of Richard L. Dolsky, M.D., and Collagen Corporation (Collagen). Because we find no error of law in the trial court's grant of summary judgment on the basis of federal preemption, we affirm.

Irene Green developed an auto-immune disease after being treated with Zyderm Collagen Implant (Zyderm). Zyderm, which is manufactured by Collagen, is administered by sub-cutaneous injections to improve soft tissue deficiencies, and it is regulated under the MDA. The Federal Food and Drug Administration (FDA) has classified Zyderm as a Class III medical device that must be approved by the FDA prior to marketing. In July 1981, the FDA issued an order granting Collagen permission to market Zyderm. In 1992, the FDA reaffirmed that order.

Green filed suit against Collagen upon the theories of negligence, strict liability, breach of warranty, and fraud in obtaining FDA approval to market Zyderm. Green also sought punitive damages from Collagen. In addition, Green sued Dr. Dolsky upon the theories of negligence, failure to warn and failure to obtain informed consent. Green's husband joined the action seeking damages from both Collagen and Dr. Dolsky for loss of consortium.

Collagen filed a motion for summary judgment on the basis that the MDA expressly preempt all of the Greens' state tort law claims. Following oral arguments, the trial court granted Collagen's motion for summary judgment. The Greens now appeal.

The sole issue on appeal is whether the trial court erred in granting summary judgment in favor of Collagen on the basis that the MDA preempted the Greens' state tort law claims.

We review a trial court's grant of summary judgment under the following standard:

Summary judgment shall be entered:

... if the pleadings, depositions, answers to interrogatories, and admissions on file, together with the affidavits, if any, show that there is no genuine issue as to any material fact and that the moving party is entitled to a judgment as a matter of law. Pa.R.C.P. 1035(b). "The record must be viewed in the light most favorable to the nonmoving party, and all doubts as to the existence of a genuine issue of material fact must be resolved against the moving party." Marks v. Tasman, 527 Pa. 132, , 589 A.2d 205, 206 (1991). Summary judgment may be entered only in cases where the right is clear and free from doubt. Musser v. Vilsmeier Auction Co., Inc., 522 Pa. 367, 369, 562 A.2d 279, 280 (1989).

Hayward v. Medical Center, 530 Pa. 320, 324, 608 A.2d 1040, 1042 (1992). See also Myszkowski v. Penn Stroud Hotel, Inc., 430 Pa.Super. 315, 320, 634 A.2d 622, 625 (1993). A trial court's grant of summary judgment will only be reversed for an error of law or a clear abuse of discretion. Myszkowski, at 320, 634 A.2d at 625.

Preliminarily, we note that neither our supreme court, nor this Court, nor the Third Circuit Court of Appeals, has addressed the issue of federal preemption of state tort law claims involving Class III medical devices which have received pre-market approval by the FDA. Recently, however, the United States District Court for the Eastern District of Pennsylvania addressed this issue, and held that the MDA wholly preempt a plaintiff's state tort law claims in cases involving Class III medical devices which have received pre-market approval. Michael v. Shiley, Inc., et al., No. 93-1729, 1994 WL 59349 (E.D.Pa. February 25, 1994). "While decisions of the lower federal courts have a persuasive authority, they are not binding on Pennsylvania courts even where they concern federal questions." Commonwealth v. Giffin, 407 Pa.Super. 15, 26, 595 A.2d 101, 107 (1991), citing Hangelias v. Dawson, 158 Pa.Super. 370, 374, 45 A.2d 392, 394 (1946). However, because we find the reasoning of the district court in Michael to be persuasive, we find no error of law in the trial court's grant of summary judgment on the basis of federal preemption.

Under the supremacy clause of the United States Constitution, federal law is "the supreme Law of the Land; and the Judges in every State shall be bound thereby, any Thing in the Constitution or Laws of any State to the Contrary notwithstanding." U.S. Const. art. VI, cl. 2. As a result, all conflicts between federal and state laws must be resolved in favor of federal law. Buzzard v. Roadrunner Trucking, Inc., 966 F.2d 777 (3d Cir.1992). In determining whether a conflict between state and federal law exists, a court looks to congressional intent. FMC Corp. v. Holliday, 498 U.S. 52, 111 S.Ct. 403, 112 L.Ed.2d 356 (1990), appeal after remand, 932 F.2d 959 (1991).

Generally, preemption may be express or implied, and it is compelled whether Congress' command is explicitly stated in the statute's language or implicitly contained in its structure and purpose. Id. 498 U.S. at 56-57, 111 S.Ct. at 407, 112 L.Ed.2d at 363. "Congress' enactment of a provision defining the preemptive reach of a statute implies that matters beyond that reach are not preempted." Cipollone v. Liggett Group, Inc., 505 U.S. 504, ----, 112 S.Ct. 2608, 2618, 120 L.Ed.2d 407, 423 (1992) (holding that the Federal Cigarette Labeling and Advertising Act of 1965 and its amendment preempted some but not all of a lung cancer victim's state law tort claims). When Congress is silent on the matter, state law will be preempted by federal law "when (a) compliance with both state and federal law is impossible or, (b) when state law stands as an impediment to a federal purpose." Hunsaker v. Surgidev Corp., 818 F.Supp. 744, 747 (M.D.Pa.1992).

Pursuant to the MDA, the FDA classifies all medical devices into one of three categories. 21 U.S.C. § 360c. Class I devices, such as tongue depressors, present little or no threat to public health and are thus subject to only general controls on manufacturing. 21 U.S.C. § 360c(a)(1)(A); see also Stamps v. Collagen Corp., 984 F.2d 1416, 1418 (5th Cir.1993), cert. denied, 510 U.S. 824, 114 S.Ct. 86, 126 L.Ed.2d 54 (1993). Class II devices, such as tampons and oxygen masks used in anesthesiology, pose more of a threat to public health and thus, are subject to more stringent controls. 21 U.S.C. § 360c(a)(1)(B); Stamps, 984 F.2d at 1418. Finally, Class III devices, such as Zyderm, are subject to the most extensive controls "to provide reasonable assurance of ... safety and effectiveness." 21 U.S.C. § 360c(a)(1)(C); Stamps, 984 F.2d at 1419. Class III devices must obtain pre-market approval from the FDA because they "present a potential unreasonable risk of illness or injury." 21 U.S.C. § 360c(a)(1)(C)(ii)(II).

Section 360e of the MDA sets forth the procedures for pre-market approval, and provides, in pertinent part:

§ 360e. Premarket approval

(a) General requirement

A class III device--

(1) which is subject to a regulation promulgated under subsection (b) of this section; or

(2) which is a class III device ... is required to have ... an approval under this section of an application for premarket approval.

* * * * * *

(c) Application for premarket approval

(1) Any person may file with the Secretary an application for premarket approval for a class III device. Such an application for a device shall contain--

(A) full reports of all information, published or known to or which should reasonably be known to the applicant, concerning investigations which have been made to show whether or not such device is safe and effective;

(B) a full statement of the components, ingredients, and properties and of the principle or principles of operation, of such device;

(C) a full description of the methods used in, and the facilities and controls used for, the manufacture, processing, and, when relevant, packing and installation of, such device;

(D) an identifying reference to any performance standard under section 360d of this title which would be applicable to any aspect of such device if it were a class II device, and either adequate information to show that such aspect of such device fully meets such performance standard or adequate information to justify any deviation from such standard;

(E) such samples of such device and of components thereof as the Secretary may reasonably require, except that where the submission of such samples is impracticable or unduly burdensome, the requirement of this subparagraph may be met by the submission of complete information concerning the location of one or more such devices readily available for examination and testing;

(F) specimens of the labeling proposed to be used for such device; and

(G) such other information relevant to the subject matter of the application as the Secretary, with the concurrence of the appropriate panel under section 360c of this title, may require.

21 U.S.C. § 360e(c)(1)(A)-(G).

Thus, the extensive pre-market approval process requires a manufacturer to submit a detailed application to the FDA, including information pertaining to product specifications, intended use, manufacturing methods, and proposed labeling. An appointed panel of experts conducts a comprehensive review of the application and prepares a report and recommendation. 21 U.S.C. § 360e(c)(2). Within six months of receipt of the...